With former notified body leaders on staff including Amie Smirthwaite, former Global Head of Clinical Compliance at BSI, and a team of seasoned experts dedicated to PERs, we have unique insights into what notified bodies will accept and creative strategies for how to respond to nonconformities.
Our global team has a unique combination of clinical and regulatory expertise, with a deep understanding of how IVDs work, how performance is measured, and what type of clinical evidence and analysis is required.
Led by our clinical team project managers, the RQM+ process begins with gaining a thorough understanding of your products, business objectives, and regulatory strategy. With a focus on demonstrating sufficient clinical data, we will help you implement innovative strategies for using existing data along with helping you create a PMPF plan to meet reviewer expectations.
The RQM+ validated process includes development of the PEP, literature search protocols/reports, and compilation of the PER which includes the state of the art analysis, scientific validity report, analytical performance report, and clinical performance report. We have multiple checkpoints with our clients to maintain alignment, as well as an internal review of the documents to provide the highest quality PER. The clinical regulatory strategy is applied throughout the process to ensure the result meets both yours and the notified body's expectations.
Using our performance evidence matrix and a comprehensive approach to gathering data across multiple departments, we will help you clearly identify gaps and weaknesses in data. We will then help you create a plan for the future, including rationales, justifications, and PMPF planning. Our integrated approach provides a complete picture for reviewers so that they can feel confident in approving the product for CE marking.
Seamless integration of PERs, PMS, and risk management is essential for more than just compliance—it will also save you money. Proper integration ensures data flows consistently across multiple procedures and departments. Why waste valuable resource time by having one department reproduce or reformat data to resolve inconsistencies in procedures and templates? RQM+ will ensure efficiency and effectiveness across the business, reducing opportunities for errors and nonconformities.
Learn more about our complete IVDR Clinical Evidence and PMS Solution
Performance evaluation reports and other documentation must be updated regularly to stay compliant. We can take on routine maintenance on a predetermined schedule so you don’t have to worry about missing deadlines or burdening your internal resources or burdening your internal resources who need to be focused on new products.